BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERONOX NITRIC OXIDE DELIVERY DEVICE

    MDR report key: 8314379 · Received February 7, 2019

    Report

    Report Number
    8314379
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 25, 2019
    Report Date
    February 1, 2019
    Manufacturer
    INTERNATIONAL BIOMEDICAL, LTD.
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE WALKING DOWN THE HALL AT NEWBORN INTENSIVE CARE UNIT (NICU) TO TRANSPORT A PATIENT, THE AERONOX 2.0 TURNED OFF. THE UNIT WAS PLUGGED IN AND CHARGED PRIOR TO USE. NO HARM TO PATIENT REPORTED. MANUFACTURER RESPONSE FOR APPARATUS, NITRIC OXIDE DELIVERY, AERONOX NITRIC OXIDE DELIVERY DEVICE (PER SITE REPORTER). MANUFACTURER WAS INFORMED TODAY ABOUT THE PROBLEM. THERE IS NO OFFICIAL RESPONSE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108370 AERONOX NITRIC OXIDE DELIVERY DEVICE APPARATUS, NITRIC OXIDE DELIVERY MRN INTERNATIONAL BIOMEDICAL, LTD. AERONOX

    Patients

    Seq Age Sex Outcome Treatment
    1